Job Description

Seeking an experienced Staff Quality Assurance Specialist to lead and enhance quality management systems within a regulated medical device environment, requiring expertise in international quality standards, regulatory compliance, and supplier quality management.

Responsibilities

• Lead quality management system development and maintenance
• Drive quality system improvements and modernization
• Serve as quality liaison with regulatory bodies
• Develop and maintain quality policies and procedures
• Plan and conduct internal and external quality audits
• Lead supplier audits and certification processes
• Coordinate and support regulatory audits and inspections
• Investigate quality system nonconformances and implement CAPA
• Establish and maintain supplier qualification and monitoring programs
• Develop supplier quality agreements and performance metrics
• Lead supplier corrective action processes
• Collaborate with procurement and engineering teams
• Implement and maintain risk management processes
• Lead quality improvement initiatives
• Conduct management reviews and present quality metrics
• Champion quality culture through training and mentoring
• Ensure quality documentation meets regulatory requirements
• Develop and deliver training programs
• Maintain knowledge of evolving regulatory requirements

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field
• Minimum 10-12 years of quality assurance experience in medical device or regulated manufacturing
• Extensive experience with ISO 13485
• Comprehensive knowledge of 21 CFR Part 820
• Proven track record in conducting internal and external quality audits
• Advanced supplier quality management experience
• Strong understanding of risk management principles and ISO 14971
• Experience with design controls, document control, and other QMS elements
• Knowledge of additional regulatory standards
• Lead Auditor certification for ISO 13485 required
• Exceptional analytical and problem-solving skills
• Strong leadership capabilities
• Excellent written and verbal communication skills
• Proficiency in quality management software and statistical analysis tools
• Ability to work independently while managing multiple priorities

Benefits

• No benefits